Kornimate/medical-research-clean huggingface dataset:
comparison arterial blood pressure and cardiac index-based hemodynamic management on postoperative myocardial injury

Conditions: Myocardial Injury; Perioperative/Postoperative Complications

Summary: the primary aim of this study is to compare mean arterial pressure (map) and cardiac index (ci) based intraoperative hemodynamic management in terms of postoperative high sensitive troponin elevation. the hypothesis of the study is that there will be at least 5ng/l difference between the two groups in terms of troponin elevation occurring in the postoperative period. when power analysis was performed with this primary output, it was calculated that while alpha was 0.05 beta 0.2, 42 patients in each group, a total of 84 patients were required.

fluid therapy will be started as 2-4 ml/kg/h, according to the clinician's decision for the patient. afterwards, patients will be managed hemodynamically with one of the map and ci algorithms. targeted fluid therapy will be administered in accordance with the following definitions of normal and algorithms for both groups. normal definitions: map: baseline map +/- 20% and map\>65mmhg baseline map: map average in the ward at rest the day before surgery ci: baseline ci +/- 20% and ci \> 2.2 l/m2/min baseline ci: ci calculated by mostcare monitor before the anesthesia induction starts low map intervention if ppv\>14, apply 500ml crystalloid if ppv\>9 and any additional finding regarding hypovolemia, apply 500ml crystalloid if ppv\<10, start/titrate noradrenaline infusion low ci intervention if ppv\>9, apply mini fluid challenge (mfc). if mfc is positive, apply 500ml crystalloid. if mfc is negative, evaluate map. if map is elevated start/titrate remifentanil. if map is not elevated start/titrate dopamine/dobutamine in accordance with svri

Eligibility criteria:
inclusion criteria: 1. patients who will undergo pancreatic-hepatic surgery 2. patients over 65 years of age or patients over 45 years of age and with at least one of the following comorbidities: coronary artery disease, congestive heart failure, moderate to severe heart valve disease, peripheral artery disease moderate to severe pulmonary hypertension, cerebrovascular accident older than 1 month, history of pulmonary embolism more than 1 month old, diabetes mellitus, hypertension exclusion criteria: 1. presence of atrial fibrillation, sepsis, pulmonary embolism 2. presence of pulmonary embolism, acute coronary syndrome and cerebrovascular accident in the last month 3. static respiratory system compliance \< 35ml/cmh2o 4. patients with preoperative high sensitive troponin t value \>65ng/liter 5. glomerular filtration rate \< 60 ml/min exclusion criteria during the protocol: 1. newly developed arrhythmia, embolism, sepsis, 2. cancellation of planned surgery 3. postoperative hepatic failure defined as inr\>2
impar vs coccygeal block in the treatment of coccidine

Conditions: Coccyx Injury; Coccygeal Body Tumor

Summary: the aim of this study was to evaluate the efficacy of coccygeal nerve blockade. impar sympathetic ganglion blockade is a common treatment method used in coccygeal pain. however, experience with the coccygeal nerve is scarce in the literature. the investigator planned to follow up coccidynia patients who underwent impar sympathetic ganglion blockade and coccygeal nerve blockade for 3 months after the procedure. the investigator's aim is to compare the efficacy of coccygeal nerve blockade with impar blockade.

patients with coccygeal pain will be evaluated. patients with organic pathology such as malignancy and infection on imaging and investigations will be excluded. seventy-four patients diagnosed with traumatic or idiopathic coccidynia will be included in the study. patients will be randomised by computer programme. half of them will undergo ultrasound-guided pericoccygeal nerve blockade and the other half will undergo fluoroscopy-guided impar sympathetic ganglion blockade. pericoccygeal nerve block is performed with the patients lying in the prone position. the sacral horns are visualised using a linear probe. the coccygeal nerves are captured medial to the sacral cornuas and a combination of local anaesthetic and dexamethasone is injected. impar sympathetic ganglion blockade it is performed in the operating theatre with the patient in the prone position. the sacrum and coccyx are visualised with a lateral view. a needle is inserted through the sacrococcygeal junction and a combination of local anaesthetic and dexamethasone is injected when an optimal image is obtained with contrast material injection. patients will be evaluated before, 1 and 3 months after the procedure by filling out the visual analogue scale and paris functional coxidynia questionnaire. the investigator who evaluates the patients and collects the data after the procedure will be blinded.

Eligibility criteria:
inclusion criteria: * coccygeal pain exclusion criteria: * malignite * infection * pregnancy

Keywords: coccigodynia coccigeal pain treatment pericoccigeal nerve block impar ganglion block
a study of patients with dry mouth and sticky saliva during radiotherapy

Conditions: Xerostomia

Summary: the purpose of this study is to evaluate the clinical safety and effectiveness of visco-ease dry mouth spray for the treatment of radiotherapy induced xerostomia (rix) in head and neck cancer patients. a parallel group double blind study design has been selected. the primary outcome is change in grix scores from baseline (visit 1) to end of treatment (visit 7). the primary outcome will be compared between visco-ease and the placebo treatment.


Eligibility criteria:
inclusion criteria: 1. subject has provided written informed consent 2. male or female subjects ≥ 18 years of age 3. subjects prescribed radiotherapy or chemoradiotherapy as primary treatment for head and neck tumours where one or more parotid glands will receive a significant dose of radiation as judged by the ci or pi during the radiotherapy planning process exclusion criteria: 1. subject is pregnant or breastfeeding 2. subjects with known allergies to egg, soya, or lanolin (sheep's wool grease) based products 3. subjects with a history of an autoimmune disease with pre-treatment xerostomia (e.g. sjögren's syndrome) or other underlying systemic illness known to cause xerostomia independent of prior radiation therapy exposure 4. subjects who have participated in an investigational medicinal product study within 30 days prior to signing consent 5. any clinically significant disease or condition that may interfere with the study treatment or outcome of the study (at the discretion of the ci or pi) 6. subjects who are unable to independently complete the questionnaire or diary 7. subjects who are judged inappropriate for inclusion in the study by the ci or pi 8. subjects with head and neck cancer who have had surgery to the primary site. neck dissection alone is not an exclusion

Keywords: radiotherapy induced xerostomia (rix)
effect of foot bath on the severity of pain, fatigue and insomnia in patients with acute renal failure

Conditions: Renal Failure; Pain

Summary: one of the non-pharmacological methods that is easily applied, tolerated by the patient, and has no significant side effects is the foot bath. the aim of this study is to determine the effect of a foot bath applied to patients with acute renal failure on the severity of pain, fatigue, and insomnia.

introduction: one of the non-pharmacological methods that is easily applied, tolerated by the patient, and has no significant side effects is the foot bath. objective: the aim of this study is to determine the effect of a foot bath applied to patients with acute renal failure on the severity of pain, fatigue, and insomnia. method: the sample of this study will consist of 54 individuals who meet the inclusion criteria among patients with acute renal failure hospitalized in the internal medicine department of a training and research hospital in amasya. the research data will be collected using a personal information form, numerical pain scale, fatigue severity scale, and insomnia severity index. conclusion: in diseases such as acute renal failure that develop suddenly and require hospitalization, it is important to use and evaluate the effectiveness of simple, applicable non-pharmacological methods in order to quickly control the symptoms of patients and ensure their comfort. the study results will contribute to the literature in this field.

Eligibility criteria:
inclusion criteria: * those over the age of 18 * those hospitalized in the internal medicine clinic with a diagnosis of acute renal failure * those who speak and understand turkish * those who consent to participate in the study exclusion criteria: * those with cognitive dysfunction * those diagnosed with chronic renal failure * those with wounds on their feet * those whose vital signs are not within normal limits (fever, high blood pressure, bradycardia, tachycardia, etc.) * those receiving hemodialysis treatment for acute renal failure * those taking medication for insomnia * those who did not consent to participate in the study

Keywords: foot bath insomnia fatigue
correlation study of vascular parameters in hypertensive men with erectile dysfunction

Conditions: Erectile Dysfunction; Arterial Hypertension; Endothelial Dysfunction

Summary: the purpose of the study is to assess the correlation of fmd of brachial artery and carotid intima media thickness with ed severity and clinical response to vardenafil in hypertensive men.

to achieve this objective, a prospective study will be conducted, with hypertensive patients ranging from 50 to 70 years, presenting vasculogenic erectile dysfunction for over six months and sexually actives. all patients will be assessed for clinical and laboratorial data, endothelial dysfunction, endothelium independent vasodilation and carotid intima media thickness at the inclusion of the study. they will receive medical orientations from the same urologist and will return after four attempts with 20 mg of vardenafil.

Eligibility criteria:
inclusion criteria: * arterial hypertension and erectile dysfunction of vascular origin for at least 6 month exclusion criteria: * other condition that cause erectile dysfunction such as depression, hypogonadism, surgery, trauma, major cardiovascular event

Keywords: erectile dysfunction arterial hypertension flow mediated vasodilation endothelial dysfunction carotid intima media thickness vardenafil
evaluation of the quantra qstat system in obstetric patients

Conditions: Blood Loss Massive; Post Operative Hemorrhage

Summary: this pilot study will assess the performance of the quantra system with the qstat cartridge versus standard of care coagulation testing in bleeding pregnant women at delivery.

the quantra system is a fully integrated and automated in vitro diagnostic device which uses seer sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. the qstat cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies including fibrinolytic defects. these patients include the tobstetric hemorrhage population. the cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system. this single-center, prospective, observational pilot study will evaluate the performance of the quantra system with the qstat cartridge as compared to standard of care coagulation testing in bleeding pregnant women at delivery.

Eligibility criteria:
inclusion criteria: * subject is \> 18 years. * subject is pregnant or at least 24 h postpartum * subject is fluent in english language. * subject is experiencing significant bleeding resulting in activation of the stage 2 ob hemorrhage protocol as defined by blood loss ≥1500ml at delivery or within the first 24 hours after delivery, and/or is hemodynamically unstable and/or is experiencing increased abnormal bleeding not responsive to ob stage 1 hemorrhage resuscitation. * subject or subject's legally authorized representative (lar) is willing to provide informed consent, either prospectively or by deferred consent. exclusion criteria: * subject is incarcerated at the time of the study. * subject is currently enrolled in a distinct study that might confound the results of the proposed study * subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks

Keywords: quantra viscoelastic testing coagulation
analysis of postural transitions in subjects affected by parkinson disease

Conditions: Parkinson Disease

Summary: this observational trial aims to evaluate the effect of rehabilitation on postural transfers (pts) in subjects affected by parkinson disease. the pts are evaluated by an inertial sensor (a device composed by an accelerometer, a gyroscope and a magnetometer) attached to the subjects. the data obtained by the inertial sensor are kinematic (e.g. acceleration and angular speed) and spatiotemporal parameters (e.g. time to completion and velocity). additional clinical evaluations are carried out at the beginning and end of the rehabilitative intervention.


Eligibility criteria:
inclusion criteria: * subjects with idiopathic parkinson's disease; * subjects should be in a positive therapeutic window or in the on phase during the evaluations; * subjects must be able to walk at least 10 meters independently with or without any walking aid exclusion criteria: * non-clinically stable subjects; * subjects in off phase during the evaluations; * other neurological conditions (e.g. stroke, peripheral neuropathies, etc.); * other pathologies that can negatively influence the subject's walking ability (e.g. surgery at the lower limbs in the previous 6 months, important deformities at the lower limbs, etc.)

Keywords: parkinson disease rehabilitation postural transfers
quantification of nlrp3 (rs4612666) and card8 gene (rs2043211) in generalized chronic periodontitis subjects

Conditions: Periodontal Diseases; Coronary Artery Disease

Summary: quantification of nlrp3 (rs4612666) and card8 (rs20432111) will be analysed in the subgingival plaque and blood samples of generalized chronic periodontitis with and without coronary heart disease. the demographic and the periodontal parameters were assessed and correlated with the quantification of nlrp3 (rs4612666) and card8 (rs2043211) was analysed with rt-pcr

the study is done in order to assess the demographic variables such as age, height, weight and socio-economic status, bmi, personal habits, waist-hip ratio, lipid profile, use of medications, and family history of coronary artery disease in generalised chronic periodontitis subjects with and without coronary artery disease. to assess and compare the periodontal status of generalised chronic periodontitis subjects with and without coronary artery disease. to determine the expression of nlrp3 (rs4612666) and card8 gene (rs2043211) polymorphisms in subgingival tissue samples of generalised chronic gingivitis periodontitis subjects with and without coronary artery disease. to correlate the demographic variables and periodontal parameters and the expression of nlrp3 (rs4612666) and card8 (rs2043211) gene polymorphisms in generalised chronic periodontitis patients with coronary artery disease and compare them with systemically healthy chronic periodontitis patients

Eligibility criteria:
inclusion criteria: * patients willing to participate in the study * patients within the age group of 30-65 years ( male ) * patients should have ≥ 20 remaining natural teeth * no history of long term antibiotic use in the past 6 months * for group i generalized chronic periodontitis patients with coronary heart disease * for group ii generalized chronic periodontitis patients without coronary heart disease exclusion criteria: * patients with systemic conditions such as type i, and type ii diabetes mellitus, respiratory diseases, renal disease, liver disease, rheumatoid arthritis, allergy, advanced malignancies and hiv infection will be excluded from the present investigation. * patients on drugs such as corticosteroids, antibiotics within 3 months of investigation will be excluded. * current smokers, individuals who quit smoking less than 6 months ago. * patients who had undergone periodontal therapy within the previous 6 months

Keywords: nlrp3 (rs4612666), card8 (rs20432111)
popliteal plexus block for total knee arthroplasty

Conditions: Pain, Postoperative

Summary: this study aims to assess the analgesic effect of the popliteal plexus block as a supplement to a femoral triangle block in patients undergoing total knee arthroplasty

a femoral triangle block (ftb) effectively anesthetizes the anterior group of nerves innervating the knee (infrapatellar branch of the saphenous nerve, the medial femoral cutaneous nerve and the terminal branch of the medial vastus muscle nerve). however, the posterior group of nerves innervating the knee joint is not covered with an ftb, and therefore most patients complain of significant, opioid-requiring pain despite a successful ftb. the posterior group consists of the popliteal plexus, which is derived from the tibial nerve and the posterior branch of the obturator nerve. the popliteal plexus is located in the popliteal fossa, where it entwines the popliteal artery and vein. recent cadaver studies have suggested that an injection into the distal part of the adductor canal will spread to the popliteal fossa (pubmed identifier (id): 28937534; pubmed id: 27442773). this study aims to assess the analgesic effect of the popliteal plexus block (ppb) as a supplement to a femoral triangle block (ftb) after total knee arthroplasty (tka). in the study all patients will receive an ftb with 10 ml bupivacaine-epinephrine (0.5%-1:200,000) with the addition of 0.5 ml dexamethasone (4 mg/ml). all patients are postoperatively observed for the development of significant pain (nrs \> 3) in the primary observation period (pop) defined as: a 3-hour observation period starting at the return of completely normal cutaneous sensation (lateral thigh and lateral side of the lower leg) after spinal anesthesia. if the patient reports pain (nrs \> 3) in the pop, the patient will be randomized to the study treatment - a ppb with 10 ml bupivacaine-epinephrine or 10 ml saline.

Eligibility criteria:
inclusion criteria: * male or female at least 50 years of age at screening * scheduled to undergo primary total knee arthroplasty in spinal anesthesia * normal sensory function at the lateral part of the thigh and lower leg * american society of anesthesiologists (asa) physical status 1, 2, or 3 * able to provide informed consent exclusion criteria: * unable to cooperate and follow the study protocol * communication problems * allergic towards any medical product administered in the study * diabetes requiring medical treatment * pregnancy (a pregnancy test will be conducted on all women of childbearing potential prior to inclusion in the study. a positive test result will result in exclusion from the study) * preoperative opioid treatment (dosed \> once daily)

Keywords: arthroplasty, replacement, knee anesthetics, local pain, postoperative nerve block bupivacaine epinephrine
telemonitoring of chronic wound patients using myderm, a digital solution: feasibility study

Conditions: Single Chronic Wound; Lower Limb Wound

Summary: the aim of this study is to assess the feasibility of integrating myderm for remote monitoring of chronic wounds into everyday practice, for patients over 18 years of age suffering from a single chronic wound of the lower limb (more than 6 weeks old). outcome measure 1 : evaluate patient satisfaction after 2 months of using the myderm solution. outcome measure 2 : 1. evaluate caregiver satisfaction after 2 months of patient use of myderm solution. 2. assess patient use (compliance, frequency) of myderm solution 3. evaluate caregiver use of pixacare solution 4. evaluate the impact of patients' socio-demographic characteristics (age, gender, level of education: primary/secondary/tertiary, rural/urban) on use of the myderm solution. 5. evaluate the impact of patients' clinical characteristics on the use of the myderm solution. researchers will compare standard of care arm vs remote monitoring arm. as part of remote monitoring, patients are invited to take photos of their wounds using their smartphone, and to answer a simple questionnaire to look for signs of complications. to assess satisfaction, the patient will complete a questionnaire after 2 months' use, using a 7-level likert scale.

observational, monocentric study of patients with chronic wounds of the lower limb benefiting from the digital solution for remote monitoring of wound healing. clinical data will be collected by the investigating team during the primary consultation. patient satisfaction surveys will be sent in paper format to patients at the consultation scheduled at the end of the two-month follow-up period. caregiver" satisfaction surveys will be sent in paper format to caregivers at the end of the study. the number of actions taken in response to an alert (by telephone, by message, organization of a physical consultation, organization of a teleconsultation, hospitalization) will be recorded in the post-alert action traceability form

Eligibility criteria:
inclusion criteria: * patient with a single chronic wound of the lower limb (more than 6 weeks) * benefiting from the myderm digital wound-healing monitoring solution * patient aged 18 or over * informed patient who has not objected to the use of data exclusion criteria: * patient refusing to participate in the study * patient included in a clinical trial * patient with a life expectancy shorter than the duration of the study * patient with cognitive impairment * inability to install or use the medical device for technical reasons (lack of internet connection, lack of 4g coverage or more, lack of smartphone) * patient requiring home hospital care * patient requiring follow-up and rehabilitation care * pregnant or breast-feeding women * patient with a previously infected wound

Keywords: chronic wound telemonitoring patient satisfaction caregivers satisfaction
non-interventional study -observe treatment efficacy in maintaining symptoms control in schizophrenia with seroquel xr

Conditions: Schizophrenia

Summary: the primary purpose of the study is to observe symptoms control in schizophrenia for 6 months in patients treated with seroquel xr. please note: seroquel sr and seroquel xr refer to the same formulation. the sr designation was changed to xr after consultation with fda.


Eligibility criteria:
inclusion criteria: * patients will have a diagnosis of schizophrenia , as defined by dsm-iv-tr and their symptoms are controlled with seroquel xr therapy started approximately 1 month before * all eligible patients will be included in the protocol provided they will receive detailed information in advance and will sign consent to grant access to their own data collected during this programme. exclusion criteria: * all the patients who have a known hypersensitivity to seroquel xr/quetiapine or any of its excipients will not be included in this study. * as per valid romanian smpc, concomitant medication, that could result in drug interactions and could jeopardise patient safety will be carefully considered before having the patient enrolled.

Keywords: schizophrenia